QVL
- 产品代码
- QVL
- 器械名称
- Absorbable Gel For Intraoperative Use In Spine Surgery
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 888.3047
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 2 件
FDA 分类定义
This device is an absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. The device is intended as an adjunct to the surgical procedure to reduce pain and neurological symptoms.
该代码近三年的 510(k)(2 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253326 | 2026-05-01 | Fziomed, Inc. | Oxiplex | |
| DEN240038 | 2025-06-17 | Fziomed, Inc. | Oxiplex® | — |
FDA 官方分类页: QVL
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。